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Z-2775-2024Class II

Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A...

MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-04-08 / Open, Classified
FDA source (opens on fda.gov)

MEDLINE INDUSTRIES, LP - Northfield began a recall of Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pack Name DYNDH1512A; 3)... on . FDA classified it as Class II and gives the reason as "Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-2775-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Product
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pack Name MNS12670A; 2) BREAST BIOPSY KIT, Pack Name DYNDH1512A; 3) CIRCUMCISION TRAY, Pack Name CIT6720; 4) CIRCUMCISION TRAY, Pack Name CIT6715; 5) CIRCUMCISION TRAY, Pack Name CIT7020; 6) CIRCUMCISION TRAY, Pack Name DYNDA2271; 7) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Name CIT6920; 8) NURSERY CIRCUMCISION TRAY, Pack Name CIT4845; 9) PUNCH BIOPSY KIT, Pack Name MNS8245; 10) STERILE 1CC SYR W/ 27GX1/2 NDL, Pack Name DYNDA2496
Product code
LRO General Surgery Tray
Reason for recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
FDA root cause
Under Investigation by firm
Action
Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request that the syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.
Distribution
Worldwide distribution.
Product codes and lots
MNS12670A, Lot Number 2022011090; MNS12670A, Lot Number 2022070690; MNS12670A, Lot Number 2023022190; MNS12670A, Lot Number 2023101890; MNS12670A, Lot Number 2024021590; DYNDH1512A, Lot Number 2022121990; DYNDH1512A, Lot Number 2023101890; CIT6720, Lot Number 2021061490; CIT6715, Lot Number 2022100490; CIT7020, Lot Number 2023010690; DYNDA2271, Lot Number 2023022190; CIT6715, Lot Number 2023082290; CIT7020, Lot Number 2023101890; CIT6715, Lot Number 2023102090; CIT6715, Lot Number 2023120590; CIT6920, Lot Number 2021082390; CIT4845, Lot Number 2021122150; CIT4845, Lot Number 2022052450; MNS8245, Lot Number 2023082490; DYNDA2496, Lot Number 2023012790

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2775-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2774-2024Class IIOngoingVoluntary: Firm initiated
Z-2775-2024Class IIOngoingVoluntary: Firm initiated
Z-2776-2024Class IIOngoingVoluntary: Firm initiated
Z-2777-2024Class IIOngoingVoluntary: Firm initiated
Z-2778-2024Class IIOngoingVoluntary: Firm initiated
Z-2779-2024Class IIOngoingVoluntary: Firm initiated
Z-2780-2024Class IIOngoingVoluntary: Firm initiated